Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Renal failure
研究概览
简要总结
The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients treated for Covid-19
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Patients treated for Covid-19
干预措施: Any drug used to treat Covid-19 (Drug)
结局指标
主要结局
Renal failure
时间窗: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
次要结局
- Heart failure(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- EKG disturbance(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Hepatic failure(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Anemia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Leucopenia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Vascular disease(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Toxidermia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Osteoarticular adverse event(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Death(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Acute respiratory distress syndrome(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Pulmonary embolism or pulmonary hypertension(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
研究者
Lee S Nguyen
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere